MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. G2 FILTER SYSTEM - JUGULAR; VENA CAVA FILTER

Catalog Number RF320J

Device Problems Malposition of Device (2616); Patient-Device Incompatibility (2682); Material Deformation (2976)

Patient Problem Pain (1994)

Event Date 03/17/2009

Event Type  Injury  

Manufacturer Narrative

H10: manufacturing review: a manufacturing review was not requested as the lot number reported as unknown.Investigation summary: the device was not returned for evaluation.Medical records were provided and reviewed.Approximately eleven months and twenty-three days post filter placement, a computed tomography of abdomen and pelvis showed that filter was identified which was tilted anteriorly.One of the legs was noted to be displaced superiorly.Several of the legs are also noted to perforate through the inferior vena cava.Around one year and six months later, a computed tomography of abdomen and pelvis showed that filter was noted unchanged in position.Around three years and two months later, a computed tomography of abdomen and pelvis showed that filter demonstrated anterior tilt.One of the limbs of the inferior vena cava filter appears to extend into the region of a lumbar region.Inferior vena cava filter resides at the level of the l2-l3 lumbar spine region.No appreciated acute complication is noted.Around one year and twenty-six days later, a computed tomography of abdomen and pelvis showed that filter again demonstrates mild anterior tilt at the l2-l3 level with a single limb extending into the region of the lumbar vein as well as into the adjacent vertebral body similar compared to prior examinations.Therefore, the investigation is confirmed for the reported perforation of inferior vena cava, filter tilt and filter strut bent.Based on the available information, the definitive root cause is unknown.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : device not returned.

Event Description

It was reported through the litigation process that a vena cava filter was placed in a patient with the history of morbid obesity and increased risk for deep vein thrombosis.Approximately eleven months twenty one days post filter deployment, it was alleged that the filter strut bent, tilted and perforated the inferior vena cava.It was further reported that patient experienced low back and abdominal pain.The device has not been removed and there were no reported attempts made to retrieve the filter.The current status of the patient is unknown.

• Brand Name: G2 FILTER SYSTEM - JUGULAR
• Type of Device: VENA CAVA FILTER
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): C.R. BARD, INC. (GFO); 289 bay road; queensbury 12804
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 18343201
• MDR Text Key: 330659991
• Report Number: 2020394-2023-01278
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052578
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer,Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RF320J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 48 YR
• Patient Sex: Female